Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT07751341
A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing SHR-9839(sc) for Injection and SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion in people with Advanced Esophageal Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- SHR-9839(sc) for Injection and SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 7 Sep 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of providing informed consent; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.
- Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathologically confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
- Expected survival ≥12 weeks.
- Must provide a minimum of 11 formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained tumor slides.
- Females of childbearing potential must agree to use adequate effective contraception from the date of informed consent, throughout study treatment, and for 9 months after the last dose of investigational product, and refrain from oocyte donation during this period (refer to subsequent section for detailed contraceptive requirements).
Who cannot join
- Uncontrolled or symptomatic active central nervous system (CNS) metastases without adequate prior treatment.
- History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.
- Presence of uncontrolled tumor-related pain as assessed by the Investigator.
- Severe cardiovascular or cerebrovascular diseases.
- History of interstitial lung disease (ILD) including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans organizing pneumonia), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy; or suspected/unruled-out ILD on screening imaging; or moderate-to-severe pulmonary disease severely impairing respiratory function.
- Severe infection within 4 weeks before study treatment initiation, including but not limited to bacteremia, severe pneumonia or other infectious complications requiring hospitalization; active CTCAE Grade ≥2 infection requiring systemic antibiotics within 2 weeks prior to first dose (subjects on prophylactic antibiotics e.g., for urinary tract infection prophylaxis are eligible).
Show all 13Show fewer
- History of immunodeficiency including positive HIV serology; active hepatitis B (positive HBsAg at screening plus HBV-DNA ≥2500 copies/mL /500 IU/mL or above local laboratory cutoff); or active hepatitis C (positive anti-HCV plus detectable HCV RNA).
- Active pulmonary tuberculosis within 1 year before enrollment by medical history or imaging; or prior active pulmonary tuberculosis >1 year ago without standardized anti-tuberculosis treatment.
- Toxicities/complications from prior anti-tumor therapies not recovered to NCI-CTCAE Grade ≤1 or levels specified by eligibility criteria; subjects with Grade ≤2 toxicities may enroll if deemed without safety risk by the Investigator.
- Receipt of any systemic anti-cancer therapy within 4 weeks prior to study treatment start.
- Thoracic radiotherapy >30 Gy within 24 weeks, non-thoracic radiotherapy >30 Gy within 4 weeks before first dose; palliative radiotherapy ≤30 Gy within 14 days before first dose (exception: subjects completing brain metastasis radiotherapy ≥14 days prior to first dose are permitted). For prior radioisotope therapy, a washout of at least five half-lives of the radioisotope is required before study enrollment.
- Major organ surgery (excluding core needle biopsy) or significant trauma within 4 weeks before first study drug, or planned elective surgery during trial participation; invasive minor surgery (biopsy, endoscopy, drainage procedure) within 7 days prior to first dose.
- Any other condition judged by the Investigator likely to interfere with trial conduct or subject safety, such as alcohol/drug abuse, uncontrolled severe illness (including psychiatric disorders) requiring concomitant medication, clinically significant abnormal laboratory findings, familial/social issues or other factors compromising subject safety or data integrity.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 1000142
Shaohua Ma
- Recruiting
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase II Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).
- Being tested
- SHR-9839(sc) for Injection, SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-9839(sc) for InjectionDrug
SHR-9839(sc) for Injection，dose level 1
SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin InjecionDrug
Safety run-in Stage: SHR-9839(sc) for Injection ,dose level 1 or lower dose、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion; Dose extension Stage: SHR-9839(sc) for Injection,dose according to Safety run-in Stage、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion or Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-9839(sc) for Injection |
| Treatment group B : Safety run-in Stage/Dose extension Stage | Experimental | Not described Receives: Drug: SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR：Objective Response Rate
Measured: First administration to end of treatment visit about 1year
Secondary outcomes (8)
DOR：Duration of relief
Measured: First administration to disease progression about 1 year
DCR：Disease Control Rate
Measured: First administration to disease progression about 1 year
PFS：progression-free survival
Measured: First administration to disease progression about 1 year
OS：Overall Survival
Measured: First administration until participant's death about 2 years
DLT：The Dose-Limiting Toxicity
Measured: Post-dose at day 1 to Day21
MTD： The Maximum Tolerated Dose
Measured: Post-dose at day 1 to Day21
AE：Incidence and severity of adverse events
Measured: Sign the informed consent form until Safety follow-up completed about 1 year
ADA ：Anti-Drug Antibody
Measured: Day1 pre-dose to 30 days after the last dose about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start7 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751341
- Sponsor's protocol ID
- SHR-9839-206
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase II Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07751341
- Acronym / sponsor ID
- SHR-9839-206
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-9839(sc) for Injection |
| Treatment group B : Safety run-in Stage/Dose extension Stage | Experimental | Drug: SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of providing informed consent; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.
- Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathologically confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
- Expected survival ≥12 weeks.
Key exclusion criteria (13 listed)
- Uncontrolled or symptomatic active central nervous system (CNS) metastases without adequate prior treatment.
- History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.
- Presence of uncontrolled tumor-related pain as assessed by the Investigator.
- Severe cardiovascular or cerebrovascular diseases.
- History of interstitial lung disease (ILD) including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans organizing pneumonia), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy; or suspected/unruled-out ILD on screening imaging; or moderate-to-severe pulmonary disease severely impairing respiratory function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-9839(sc) for InjectionSHR-9839(sc) for Injection，dose level 1 | Drug | Treatment group A |
| SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin InjecionSafety run-in Stage: SHR-9839(sc) for Injection ,dose level 1 or lower dose、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion; Dose extension Stage: SHR-9839(sc) for Injection,dose according to Safety run-in Stage、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion or Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion | Drug | Treatment group B : Safety run-in Stage/Dose extension Stage |
Primary outcome
ORR：Objective Response Rate
Time frame: First administration to end of treatment visit about 1year
8 secondary outcomes
DOR：Duration of relief
Time frame: First administration to disease progression about 1 year
DCR：Disease Control Rate
Time frame: First administration to disease progression about 1 year
PFS：progression-free survival
Time frame: First administration to disease progression about 1 year
OS：Overall Survival
Time frame: First administration until participant's death about 2 years
DLT：The Dose-Limiting Toxicity
Time frame: Post-dose at day 1 to Day21
MTD： The Maximum Tolerated Dose
Time frame: Post-dose at day 1 to Day21
AE：Incidence and severity of adverse events
Time frame: Sign the informed consent form until Safety follow-up completed about 1 year
ADA ：Anti-Drug Antibody
Time frame: Day1 pre-dose to 30 days after the last dose about 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Active, not recruitingPhase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-9839(sc) for Injection and SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion in people with Advanced Esophageal Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Ma (+86 021-61053363, lin.ma.lm60@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR：Objective Response Rate (time frame: First administration to end of treatment visit about 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.